Notice of Development of Rulemaking

AGENCY FOR HEALTH CARE ADMINISTRATION
Certificate of Need
RULE NO: RULE TITLE
59C-1.002: Definitions
PURPOSE AND EFFECT: The agency is proposing to amend the rule that defines terms used in Rule 59C-1, F.A.C. due to recent statutory changes. A preliminary draft of the rule amendments is included in this Notice.
SUBJECT AREA TO BE ADDRESSED: Revisions to the rule that defines terms used in Rule 59C-1, F.A.C.
SPECIFIC AUTHORITY: 408.034(6), 408.15(8) FS.
LAW IMPLEMENTED: 408.033 (1)(a), 408.036(1)-(3), 408.037(1), 408.039 ()(2), 651.118 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
TIME AND DATE: October 18, 2006, 2:00 p.m. (EST)
PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, Florida
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Karen Weaver Webb, Certificate of Need, 2727 Mahan Drive, Building 1, MS 28, Tallahassee, Florida 32308.

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

59C-1.002 Definitions

(1) "Acute care bed" means a patient accommodation or space licensed by the agency pursuant to Chapter 395, Part I, F.S., and regulated under Rule 59C-1.038, F.A.C. Acute care beds exclude neonatal intensive care beds, comprehensive medical rehabilitation beds, beds used to provide mental health services as defined under subsection (29) of this section, hospital inpatient psychiatric beds, hospital inpatient substance abuse beds, beds in distinct part skilled nursing units, and beds in long term care hospitals licensed pursuant to Chapter 395, Part I, F.S.

(2) "Applicant" means any individual, partnership, corporation, or governmental entity which has filed an application for a Ccertificate of Nneed or Certificate of Need Exemption with the agency.

(3) "Application" means the forms supplied by the agency to an applicant which are to be completed in order to be eligible to be considered for a Ccertificate of Nneed in the case of comparative and expedited Certificate of Need reviews pursuant to s.408.036(1) or (2), F.S. or a written communication requesting exemption to Certificate of Need review pursuant to s. 408.036(3), F.S. and Rule 59C-1.005, F.A.C.

(4) No change.

(5) "Batching cycle" means the grouping for comparative review of Certificate of Need applications submitted for beds, services or programs having a like Certificate of Need need methodology or licensing category in the same planning horizon and the same applicable service planning area, district, service area, or subdistrict.

(6) through (11) No change.

(12) "Comprehensive medical rehabilitation inpatient beds" means beds designated for the exclusive use for comprehensive medical rehabilitation inpatient services regulated under Rule 59C-1.005 and Rule 59C-1.039, F.A.C.

(13) "Conversion from one type of health care facility to another" means the reclassification of one licensed facility type to another licensed facility type, including reclassification from a general acute care hospital to a long term care hospital or specialty hospital, or from a long term care hospital or specialty hospital to a general acute care hospital, or from a general acute care hospital to a long term care hospital or specialty hospital provided the specialty hospital is not subject to s. 395.003(9).

(14) "Conversion of beds" means the reclassification of licensed beds from one category to another, for facilities licensed under Chapter 395, F.S., including conversion to or from acute care beds, neonatal intensive care beds, beds that provide hospital mental health services inpatient psychiatric beds, comprehensive medical rehabilitation beds, hospital inpatient substance abuse beds, distinct part skilled nursing facility beds, or beds in a long term care hospital; and, for facilities licensed under Chapter 400, Part I, F.S., conversion to or from sheltered beds and community beds.

(15) No change.

(16) "Established program" means a program for the provision of a Ccertificate of Nneed regulated institutional health service which has a valid Ccertificate of Nneed or Certificate of Need Exemption for the program or existed prior to the requirement for a Ccertificate of Nneed or Certificate of Need Exemption and has been continuously in operation, and has performed at least one institutional health service.

(17) “Exemption” means the Certificate of Need review process by which a proposal that would otherwise require a batched or expedited review certificate of need review may proceed without such a review certificate of need.

(18) through (21) No change.

(22) "Hospital inpatient psychiatric beds" means beds designated for the exclusive use of hospital inpatient psychiatric services regulated under Rule 59C-1.005, F.A.C. and Rule 59C-1.040, F.A.C.

(23) "Hospital inpatient substance abuse beds" means beds designated for the exclusive use of hospital inpatient substance abuse services regulated under Rule 59C-1.005, F.A.C. and Rule 59C-1.041, F.A.C.

(24) through (27) No change.

(28) "Long term care hospital" means a hospital licensed under Chapter 395, Part I, F.S., which meets the requirements of 42 (C.F.R.) Part 412, subpart B, paragraph 412.23(e), Code of Federal Regulations (1994), and seeks exclusion from the acute care Medicare prospective payment system for inpatient hospital services.

(29) through (31) No change.

(32) "Nursing home" means a health care facility licensed under Chapter 400, Part II, F.S.

(33) through (35) No change.

(36) "Sheltered nursing home beds" mean nursing home beds configured into a nursing home facility licensed pursuant to Chapter 400, Part II, F.S., which are located within a continuing care retirement community certified under Chapter 651, F.S., for which a certificate of need has been issued as sheltered beds, and which are regulated under Rule 59C-1.037, F.A.C.

(37) "State Agency Action Report" means the single written document prepared by the agency after reviewing a Certificate of Need comparative or expedited application, or applications where more than 1 Certificate of Need application is accepted by the agency in the same batching cycle, which sets forth the evaluation of the agency with respect to the application or applications.

(38) No change.

(39) "Substantial change in health services" means:

(a)The offering by a health care facility, through conversion of beds or other means, of a new institutional health service or a health service which has not been offered on a continuing basis by or on behalf of the health care facility within the 12-month period prior to the time such service would be offered, excluding obstetrical services; or

(b)The designation of acute care beds in a health care facility as beds regulated under Rule 59C-1.036, F.A.C., or the redesignation of such beds back to acute care beds; or

(b)(c) The conversion of a general acute care or specialty hospital licensed under Chapter 395, Part I, F.S., to a long term care hospital.

(40) "Termination of an inpatient health service" means the cessation of a health service which currently requires a Ccertificate of Nneed or Certificate of Need Exemption. It does not include the temporary cessation of a service lasting 6 months or less.

(41) "Tertiary health service" means a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service. Examples of such service include, but are not limited to, pediatric cardiac catheterization, pediatric open heart surgery, organ transplantation, specialty burn units, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. The types of tertiary services to be regulated under the Certificate of Need Program in addition to those listed in Florida Statutes include:

(a) Heart transplantation;

(b) Kidney transplantation;

(c) Liver transplantation;

(d) Bone marrow transplantation;

(e) Lung transplantation;

(f) Pancreas and islet cells transplantation; and

(g) Heart/lung transplantation;

(h) Adult open heart surgery;

(i) Long term care hospitals. Neonatal and pediatric cardiac and vascular surgery; and

(j) Pediatric oncology and hematology.

In order to determine whether services should be added or deleted, the listing shall be reviewed annually by the agency.

(42) through (43) No change.

Specific Authority: 408.034(65), 408.15(8), F.S.  Law Implemented: 408.033(1)(a), 408.036(1)(2)(3), F.S. 408.037(1), 408.039(1)(2), 651.118, F.S.  History: New 1-1-77, Joint Administrative Procedures Committee Objection Filed See F.A.W. Volume 3 No. 10 March 11, 1977. Amended 11-1-77,9-1-78, 6-5-79, 4-25-80, 2-1-81, 3-31-82, 7-29-82, 12-23-82. Formerly 10-5.02. Amended 11-17-87, 12-5-90, 1-31-91, 1-1-92. Formerly 10-5.002. Amended 12-14-92, 2-27-94, 6-23-94,10-18-95, 10-8-97, 12-12-00.